It’s official, Indian-made stents as good as the best

At the scientific session of the American Heart Association held in Chicago, cardiologists from Germany presented the results of an extended follow up of 2,603 patients who were randomised to treatment with two new generation stents — everolimus eluting Xience and sirolimus eluting Yukon Choice — and a first generation sirolimus eluting Cypher stent.Rema Nagarajan | TNN | November 15, 2018, 06:45 IST

Highlights

In February 2017, the government had capped the price of stents leading to a three-fourths reduction in the prices for drug eluting stents.,

Several multinational stent companies had threatened to withdraw their stents from India claiming that they were superior to Indian ones and hence deserved a higher price.,

After much controversy regarding the quality of stents manufactured in India, yet another study comparing an Indian stent with the foremost foreign stent brand has concluded it is just as good. After much controversy regarding the quality of stents manufactured in India, yet another study comparing an Indian stent with the foremost foreign stent brand has concluded it is just as good. On Monday, the results of a 10-year study comparing clinical outcomes of the Indian stent Yukon Choice PC with those of the market leader, Xience stents from the American company Abbott, showed that they were equally good. A study presented two months back had also concluded that another Indian stent, Supra Flex was as good as Xience.

At the scientific session of the American Heart Association held in Chicago, cardiologists from Germany presented the results of an extended follow up of 2,603 patients who were randomised to treatment with two new generation stents — everolimus eluting Xience and sirolimus eluting Yukon Choice — and a first generation sirolimus eluting Cypher stent. Cypher is not in the market any more. The study published in the journal of the AHA showed there was no difference in outcomes between the two new generation stents.

In February 2017, the government had capped the price of stents leading to a three-fourths reduction in the prices for drug eluting stents. Several multinational stent companies had threatened to withdraw their stents from India claiming that they were superior to Indian ones and hence deserved a higher price. Several cardiologists too had questioned the quality of Indian stents. However, with studies showing that Indian stents are as good as foreign ones, cardiologists appear to have changed tack.

“These are the kind of studies we need — large, randomised, long-term studies. More Indian companies should do such studies to establish their credibility internationally. Every stent needs to be proven,” said Dr Ashok Seth, head of cardiology for the Fortis Group of hospitals. He added that the study also showed there was no difference between stents with biodegradable polymer coating and permanent polymer coating putting paid to the argument that biodegradable polymer coated stents should get a higher price.

Dr Upendra Kaul, chairman of Batra Heart Centre, who initiated the earlier one-year study comparing Supra Flex to Xience along with Prof Patrick Serruys from the Netherlands, pointed out that even with good newer generation stents, 3% of patients still had heart attacks and needed restenosis each year. “Further research is being done to bring down this 3%,” said Dr Kaul.

Yukon stents are made in India from German technology, while Supra Flex is a fully indigenous stent, pointed out Dr Kaul. In an editorial in the journal Euro Intervention last year, Dr Kaul had written: “There is a perception in the minds of cardiologists, which gets passed on to the patients, that imported stents are superior.” He had added that it was time for Indian companies to prove to cardiologists and patients that their products were as safe and effective as those of multinational companies.

So far, no brand of drug eluting stents anywhere in the world has been shown to be superior to other brands in the market, both Dr Kaul and Dr Seth pointed out.

With immense pride “India Live” celebrated its 10th national conference in Mumbai from 28th February to 3rd March 2019. The conference turned out to be a gold mine of information, with emphasis on academics, education and exchange of knowledge with leaders in interventional cardiology from both India and abroad.